MOBIL-O-GRAPH NG 24 H ABP-CONTROL

K072446 · I.E.M. GmbH · DXN · Nov 29, 2007 · Cardiovascular

Device Facts

• Record ID: K072446
• Device Name: MOBIL-O-GRAPH NG 24 H ABP-CONTROL
• Applicant: I.E.M. GmbH
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 29, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Mobil-O-Graph NG ABPM system is an automated, microprocessor controlled blood pressure monitor which monitors, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual adult patient (in the patient's environment) for a session which may last 24 to 48 hours.

Device Story

Mobil-O-Graph NG ABPM is an automated, microprocessor-controlled blood pressure monitor; utilizes inflatable upper-arm cuff; employs oscillometric principle to measure systolic/diastolic blood pressure and heart rate. Device operates in patient's environment for 24-48 hour sessions; accumulates and stores data. Features physical design updates from predicate; includes infrared or Bluetooth connectivity for computer interfacing. Healthcare providers use stored data to assess patient blood pressure profiles; aids in clinical decision-making regarding hypertension management.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and performance characteristics compared to predicate.

Technological Characteristics

Microprocessor-controlled oscillometric blood pressure monitor; inflatable upper-arm cuff; infrared and Bluetooth connectivity for data transfer; standalone operation with computer interface capability.

Indications for Use

Indicated for adult patients requiring 24 to 48-hour ambulatory blood pressure and heart rate monitoring in their home or clinical environment.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• ABPM Mobil-O-Graph Blood Pressure Monitor (K964235)

Submission Summary (Full Text)

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K072446/51
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Image /page/0/Picture/1 description: The image shows the letters "MTC" in a large, bold, serif font. The letters are black against a white background. There is a horizontal line below the letters, and a smaller letter "M" to the right of the "C".

Media Trade Corporation

11820 Red Hibiscus Drive - Bonita Springs, FL 34135 Tel [phone] -- Fax [phone] E-mail: [e-mail] Web: www.mediatradecorp.com

## 510(k) Summary

| Submitter's Name: | NOV 29 2007<br>Guenter Ginsberg<br>Media Trade Corporation |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 11820 Red Hibiscus Drive<br>Bonita Springs, FL 34135 |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail]<br>[e-mail] |
| Contact: | Guenter Ginsberg |
| Date of Summary: | August 10, 2007 |
| Trade Name: | Mobil-O-Graph NG, 24 h ABP-Control |
| Establishment: | I.E.M. GmbH<br>Registration No. 9617476<br>Cockerillstrasse 69<br>52222 Stolberg, Germany |
| Classification | System, Measurement, Blood Pressure, Non-<br>Invasive<br>Product Code: DXN<br>Regulation No. 870.1130<br>Class: II<br>Panel: 74 (Cardiovascular) |

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K072446/51
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Page -2- (510k Summary)

| Predicate Device: | ABPM Mobil-O-Graph Blood Pressure Monitor<br>K 964235<br>Also manufactured by I.E.M. GmbH of Stolberg,<br>Germany |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | The Mobil-O-Graph NG ABPM (24 hour<br>Automatic Blood Pressure Monitor) is a fully<br>automatic table model device that measures blood<br>pressure by means of an inflatable cuff on the upper<br>arm. It employs the Oscillometric Principle. |
| Intended Use: | The Mobil-O-Graph NG ABPM system is an<br>automated, microprocessor controlled blood<br>pressure monitor which monitors, accumulates and<br>stores: heart beat (rate), systolic and diastolic data<br>of an individual adult patient (in the patient's<br>environment) for a session which may last 24 to 48<br>hours. |
| Technological Characteristics: | The Mobil-O-Graph NG ABPM has the same<br>general design and performance characteristics as<br>the predicate device from I.E.M. GmbH. The main<br>difference is the physical size, shape and weight,<br>as well as the option to be interfaced with regular<br>computers via infrared or Bluetooth technology.<br>The Mobil-O-Graph NG ABPM has the same<br>intended use, general design and incorporates<br>similar materials and components, hence should<br>therefore raise no new questions of safety and<br>effectiveness.<br>This submitter concludes that the Mobil-O-Graph<br>NG ABPM is therefore substantially equivalent to<br>the predicate device "ABPM Mobil-O-Graph Blood<br>Pressure Monitor by the same Establishment: I.E.M.<br>GmbH of Stolberg, Germany. |

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle faces right and is positioned in the upper right portion of the seal. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", arranged in a circular fashion around the edge of the seal.

NDV 2 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Media Trade Corporation c/o Mr. Guenter Ginsberg President 11820 Red Hibiscus Drive Bonita Springs, FL 34135

Re: K072446

Mobil-O-Graph NG 24h ABP-Control Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system. Regulatory Class: Class II (two) Product Code: DXN Dated: November 14, 2007 Received: November 15, 2007

Dear Mr. Ginsberg:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Guenter Ginsberg

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blymmlmon fo

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use: The Mobil-O-Graph ABPM system is an automated, microprocessor controlled blood pressure monitor which monitors, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual adult patient (in the patient's environment) for a session which may last 24 to 48 hours.

Prescription Use X AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blumstein

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number 122440